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COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block

Who can join

Ages 18 to 50 · Women

Inclusion criteria:

Patient has a history of a least one of the following:

* Prior exploratory laparotomy
* History of non-obstetric open intra-abdominal surgery
* History of three or more prior cesarean deliveries
* History of intra-abdominal or pelvic adhesive disease
* History of abdominoplasty
* History of abdominal re-exploration surgery

Exclusion Criteria:

* Received general anesthesia
* History of less than 3 cesarean deliveries if do not meet other inclusion criteria
* History of chronic opioid use
* History of substance abuse (i.e. alcohol, methamphetamine/amphetamine, abuse of prescription opioid medication, or heroin use)
* History of chronic kidney disease
* Allergies to bupivacaine or oral analgesics
* Patient preference
* Cesarean hysterectomy
* Administration of ≥4mg morphine to epidural
* Loss to follow-up

About the study

To assess the effect of intraoperative transversus abdominis plane (TAP) blocks on the amount of opioid pain medications expressed as morphine milliequivalents (MME) used postoperatively in patients who have undergone cesarean delivery (CD) in the setting of complex obstetric surgery (COS).

What is being tested

• Bupivicaine intervention arm (drug)
• Placebo arm (drug)

Sponsor: University of Tennessee · Participants: 120 · Started: Jul 15, 2025

Contact the study team

• Michael VanDillen Fellow physician, PI of study, MD · Phone: 314-619-1046

Official record on ClinicalTrials.gov — NCT06925152

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.